Alexander M.
About Alexander M.
Alexander M. serves as the Senior Director of Clinical Documents, Systems and Training at Nektar Therapeutics, where he has worked since 2021. With extensive experience in clinical operations, he has held various managerial roles in notable pharmaceutical companies, focusing on Trial Master File governance and training.
Work at Nektar Therapeutics
Currently, Alexander M. holds the position of Senior Director, Clinical Documents, Systems and Training at Nektar Therapeutics, a role he has occupied since 2021. Prior to this, he served as Director in the same department starting in 2020. His responsibilities include overseeing the development of the Trial Master File (TMF) Governance group, managing TMF records, and ensuring compliance with regulatory standards. He also leads audits and inspections related to TMF and clinical systems. His work focuses on enhancing the electronic Trial Master File (eTMF) and conducting training for TMF and clinical systems.
Previous Experience in Pharmaceutical Industry
Alexander M. has extensive experience in the pharmaceutical industry, having worked at several notable companies. He was a Senior Manager in Developmental Sciences Operations at BioMarin Pharmaceutical Inc. from 2012 to 2015 and later served as Associate Director of Developmental Sciences Quality at the same company from 2016 to 2017. His career also includes roles at Genentech, where he worked as Global Study Manager III from 2007 to 2010 and as Senior Project Manager for Clinical Study Systems from 2010 to 2012. Additionally, he held positions at Almac Clinical Technologies and Gentiae Clinical Research.
Education and Expertise
While specific educational details are not provided, Alexander M. possesses considerable expertise in clinical documentation, systems management, and training within the pharmaceutical sector. His roles have involved developing processes for TMF management, overseeing compliance, and enhancing clinical systems. He is skilled in conducting training sessions and managing audits, which underscores his proficiency in regulatory compliance and operational efficiency.
Leadership in TMF Governance
At Nektar Therapeutics, Alexander M. has played a pivotal role in establishing the TMF Governance group. This initiative focuses on creating and overseeing processes related to TMF management, including master TMF index management and study-specific Standard Operating Procedure (SOP) tracking. His leadership in this area has contributed to the organization’s ability to maintain efficient and compliant TMF records.